INSTITUTE DR. RILLING INC. · 89-08 · GERMANY
For INSTITUTE DR. RILLING INC. · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer; product code is 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief; date published is 05/30/2017; address is Lilienthalweg 13 , Pliezhausen, GERMANY, verified against its source on 2026-09-16.
- Firm
- INSTITUTE DR. RILLING INC. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- GERMANY verified
- Address
- Lilienthalweg 13 , Pliezhausen, GERMANY verified
- Date published
- 05/30/2017 verified
- Product code
- 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief each item verified
- Product
- BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer each item verified
- FDA notes
- Class II device without a valid 510k | Class II device without a valid 510k each item verified
What the source says
INSTITUTE DR. RILLING INC. Date Published : 05/30/2017 Lilienthalweg 13 , Pliezhausen, GERMANY 74 M - - SX System, Network and Communication, Physiological Monitors Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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